Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-24 @ 3:53 PM
Study NCT ID:
NCT01788592
Status:
RECRUITING
Last Update Posted:
2023-06-28
First Post:
2013-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Adverse Cardiac Event', 'timeFrame': '1year', 'description': 'Death from any causes, myocardial infarction or any repeat revascularization'}], 'secondaryOutcomes': [{'measure': 'all cause Death', 'timeFrame': '1year'}, {'measure': 'Myocardial Infarction', 'timeFrame': '1year'}, {'measure': 'The composite of Death or myocardial infarction', 'timeFrame': '1year'}, {'measure': 'Any repeat revascularization', 'timeFrame': '1year'}, {'measure': 'Target vessel revascularization', 'timeFrame': '1year'}, {'measure': 'Target lesion revascularization', 'timeFrame': '1year'}, {'measure': 'New lesion revascularization', 'timeFrame': '1year'}, {'measure': 'Stent thrombosis by Academic Research Consortium criteria', 'timeFrame': '1year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'drug eluting stent'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '24092248', 'type': 'DERIVED', 'citation': 'Park SJ, Ahn JM, Park GM, Cho YR, Lee JY, Kim WJ, Han S, Kang SJ, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Park SW. Trends in the outcomes of percutaneous coronary intervention with the routine incorporation of fractional flow reserve in real practice. Eur Heart J. 2013 Nov;34(43):3353-61. doi: 10.1093/eurheartj/eht404. Epub 2013 Oct 2.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate effectiveness and safety of drug-eluting stent implantation in the "real world" daily practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive patients amenable to percutaneous coronary intervention with drug eluting stents', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* coronary disease amenable to percutaneous coronary intervention (PCI)\n* no clinical and lesion limitations\n\nExclusion Criteria:\n\n* patients with a mixture of several drug eluting stents\n* terminal illness with life expectancy less than 1 year\n* patients with cardiogenic shock'}, 'identificationModule': {'nctId': 'NCT01788592', 'briefTitle': 'Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice (ASAN PCI Registry)', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Prospective Evaluation of Drug-Eluting Stents in Routine Clinical Practice', 'orgStudyIdInfo': {'id': 'AMCCV2013-02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Drug eluting stent', 'description': 'Patients who receiving drug eluting stents'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seung-Jung Park, MD,PhD', 'role': 'CONTACT', 'email': 'sjpark@amc.seoul.kr', 'phone': '82-2-3010-4812'}, {'name': 'Jung-Min Ahn, MD', 'role': 'CONTACT', 'email': 'drjmahn@gmail.com', 'phone': '82-2-3010-5904'}, {'name': 'Seung-Jung Park, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jung-Min Ahn, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Seung-Jung Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seung-Jung Park', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine', 'investigatorFullName': 'Seung-Jung Park', 'investigatorAffiliation': 'Asan Medical Center'}}}}